Cyclarity Therapeutics Secures Approval for First-in-Human Clinical Trial

NOVATO, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) — Cyclarity Therapeutics is pleased to announce regulatory approval to begin its first-in-human clinical trial. The trial will be conducted at CMAX, one of Australia’s leading clinical research centers, in partnership with Monash University. This effort will be led by Dr. Stephen Nicholls of the Victorian Heart Institute (VHI), a distinguished leader in cardiovascular medicine. In addition to a traditional SAD/MAD phase 1 trial, the authorization includes an allowance to enroll 12 patients with Acute Coronary Syndrome (ACS) to assess the safety of UDP-003 in individuals with plaque buildup, as well as to explore anecdotal evidence of efficacy. This represents a critical first step in evaluating the potential impact of our therapy in a population with high unmet need.

Key performance indicators (KPIs):

• Clinical Trial Material (CTM): Manufacture is complete, with all supporting documentation and analysis finalized. UDP-003 is in vials and ready for administration to human participants.
• Investigational New Drug (IND) Enabling Studies: All studies have been successfully completed with no predicted toxicological liabilities, ensuring a safe path forward.
• Clinical readiness: All materials necessary for clinical trial authorization have been submitted and are in place.

This milestone marks a significant moment for Cyclarity as the trial joins Dr. Nicholls’ legacy of innovative clinical research. His previous work includes the SATURN trial for Crestor in the early 2000s, the CLEAR Outcomes trial in the 2020s that introduced bempedoic acid as a statin alternative, and the recent Muvalaplin trial targeting Lp(a), a major innovation in cardiovascular health.

“We are excited to be working with Dr. Nicholls on a groundbreaking advancement in cardiovascular care,” said CEO of Scientific Affairs Matthew O’Connor. “As we advance into being a clinical stage company, Cyclarity is focused on bringing truly disease-modifying treatments for the world’s deadliest disease into reality.”

We deeply appreciate the support we’ve received to reach this important stage and invite you to stay tuned as we continue to push the boundaries of therapeutic development. For more information, please contact press@cyclaritytx.com or visit https://cyclaritytx.com/.